Label: ACNE SOLUTIONS EMERGENCY- benzoyl peroxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 49527-718-01, 49527-718-02 - Packager: CLINIQUE LABORATORIES INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 21, 2011
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
ACTIVE INGREDIENT: BENZOYL PEROXIDE 0.5%
water [] c12-15 alkyl benzoate [] glycerin [] cetearyl alcohol [] steareth-2 [] sucrose [] steareth-20 [] polyacrylamide [] dimethicone [] glyceryl stearate [] peg-100 stearate [] acetyl glucosamine [] camellia sinensis leaf extract [] caffeine [] yeast extract (faex) [] cola nitida extract [] laminaria saccharina extract [] sea whip extract [] c13-14 isoparaffin [] butylene glycol [] laureth-7 [] chloroxylenol [] phenoxyethanol
- PURPOSE
- WARNINGS
- DO NOT USE
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WHEN USING
WHEN USING THIS PRODUCT
- SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THIS TIME. IF IRRITATION OCCURS, USE ONLY ONE TOPICAL ACNE MEDICATION AT AT TIME
- AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
- AVOID CONTACT WITH THE EYES, LIPS, AND MOUTH
- AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT
- SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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INDICATIONS & USAGE
DIRECTIONS:
- CLEANS SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT
- COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONE TO THREE TIMES DAILY
- BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO OR THREE TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR
- IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DOY OR EVERY OTHER DAY
- IF GOING OUTSIDE, USE A SUNSCREEN AFTER APPLYING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, DISCONTINUE USE OF BOTH PRODUCTS AND CONSULT A DOCTOR
- FOR BEST RESULTS, USE AFTER ACNE SOLUTIONS CLEANSING FOAM AND CLARIFYING LOTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE SOLUTIONS EMERGENCY
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49527-718 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) STEARETH-2 (UNII: V56DFE46J5) SUCROSE (UNII: C151H8M554) STEARETH-20 (UNII: L0Q8IK9E08) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) GREEN TEA LEAF (UNII: W2ZU1RY8B0) CAFFEINE (UNII: 3G6A5W338E) YEAST (UNII: 3NY3SM6B8U) COLA NITIDA SEED (UNII: PQM9SA369U) PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) LAURETH-7 (UNII: Z95S6G8201) CHLOROXYLENOL (UNII: 0F32U78V2Q) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49527-718-01 1 in 1 CARTON 1 NDC:49527-718-02 15 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/01/2000 Labeler - CLINIQUE LABORATORIES INC (173047747) Establishment Name Address ID/FEI Business Operations ESTEE LAUDER COSMETICS, LTD 205952385 manufacture Establishment Name Address ID/FEI Business Operations ESTEE LAUDER N.V. 370151326 manufacture Establishment Name Address ID/FEI Business Operations Len-Ron Manufacturing Division of Aramis Inc. 809771152 manufacture Establishment Name Address ID/FEI Business Operations Aramis Inc. 042918826 manufacture Establishment Name Address ID/FEI Business Operations Northtec Bristol 949264774 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Northtec Keystone 618107429 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Pennsylvania Distribution Center 2 828534516 manufacture, relabel, repack Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd. 255175580 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics, Ltd 253616536 manufacture Establishment Name Address ID/FEI Business Operations Estee Lauder Cosmetics Distribution Center 208579636 repack, relabel Establishment Name Address ID/FEI Business Operations Estee Lauder Kabushiki Kaisha 712808195 relabel, repack Establishment Name Address ID/FEI Business Operations Whitman Laboratories Ltd. 216866277 manufacture Establishment Name Address ID/FEI Business Operations Aveda Corporation 071352058 manufacture Establishment Name Address ID/FEI Business Operations CONTRACT PHARMACEUTICALS 248761249 manufacture